The invention relates to the field of irrigation systems, and more particularly to a disposable insertion tip for an irrigation system used for cleaning the ears or other body cavities.
Irrigation syringes are routinely known for cleaning human body cavities, such as the ears. Most commonly, a flexible and depressible bulb is fitted to a nozzle through which fluid (water) can be discharged into the ear canal of a patient.
Bulb-type irrigation devices have several drawbacks. First, the bulb capacity limits the effective usage of the device given that the bulb can retain only a relatively small quantity of water. Often and to fully irrigate a patient""s ear, the flexible bulb may have to be refilled a number of times.
Second, the pressure of the water exiting the nozzle of the device and impinging upon the ear canal can not be readily controlled in a reliable manner. This lack of control produces variable results and can in turn, cause pain and injure a patient due to the sensitivity of the tympanic membrane.
Other known irrigation devices incorporate mechanical pumps which interconnect a fluid reservoir with the nozzle. These devices are capable of producing pulsating streams of water ejecting from the nozzle opening for a sustained period of time. Besides being rather bulky and cumbersome, however, the above devices also produce sufficient amounts of both vibration and noise commonly associated with mechanical pumps. Each result is annoying and undesirable in a doctor""s office or similar setting. A further consideration concerning the above referred to devices is that the volume of the fluid reservoir, though greater than that of the flexible bulb-type devices, must also be refilled at periodic intervals.
More recently, an irrigation device such as described by U.S. Pat. No. 5,685,851, to Murphy et al., the entire contents of which are herein incorporated, includes a pressure regulator unit having an inlet port which is fluidly connected to a faucet and a discharge port which is connected to an irrigation syringe. The irrigation syringe is hand-grippable and includes a push button control which selectively restricts the flow of liquid from the pressure regulator unit. The pressure regulator unit permits connection to a continuous water source (e.g., the faucet) and includes a number of retained components including a flow limiting orifice in a supply chamber, a defined air buffer, and a check valve, in order to effectively control the pressure of water supplied by the faucet to produce a smooth and consistent continuous flow to the irrigation syringe and the patient.
A further refinement is described in copending U.S. patent application Ser. No. 09/630,884 filed Aug. 2, 2000, the entire contents of which are also herein incorporated by reference. This body cavity irrigation system also includes an irrigation syringe defined by a hand piece and an insertion tip or nozzle. The hand piece is connected to a pressure regulator unit which is similarly connected to a faucet or other continuous liquid supply and further includes inlet and return lines which are fluidly connected to an inlet cavity and an outlet cavity, respectively, provided in the insertion tip. The inlet cavity permits water to be discharged into the ear, while the outlet cavity collects waste water after it has been discharged into the ear, the waste water being returned via the return channel to a basin or sink for disposal.
It is generally preferred for health and sanitary reasons that an insertion tip, such as described immediately above, be used only for a single patient and then disposed of thereafter. For these reasons, there is a compelling need to insure that the insertion tip cannot effectively be reused.
It is a primary object of the present invention to overcome the above noted problems of the prior art.
It is another primary object of the present invention to provide a disposable insertion tip for a body cavity cleaning system, such as for irrigating the ears, wherein the insertion tip can only be used a single time; that is, the tip is ineffective after removal from an irrigation syringe.
Therefore and according to a preferred aspect of the present invention, there is provided a body cavity cleaning device, said device including a hand piece which receives a supply of liquid under pressure for cleaning a body cavity and an insertion tip. The insertion tip is releasably attachable to one end of the hand piece and includes release means for selectively releasing the insertion tip from the hand piece, wherein engagement of the release means prevents effective reuse of the insertion tip in conjunction with the body cavity cleaning device.
In addition, the insertion tip preferably includes a pair of interior chambers fluidly interconnected to the hand piece including an inlet chamber which discharges liquid into a body cavity and an outlet chamber which returning used liquid from the body cavity to a return line of the hand piece.
Preferably, the release means includes at least one tear strip which, when torn, prevents the insertion tip from being usefully reattached to the hand piece. Therefore, the insertion tip is disposable and is effective only for a single patient. The insertion tip preferably includes at least one circumferential interior protrusion or recess which provides locking engagement with a corresponding recess or protrusion provided on an engagement portion of the hand piece. The tear strip must be employed in order to unlock and remove the insertion tip from the hand piece. Once the tear strip has been removed, the sealing capability of the insertion tip with the hand piece is disabled, and the insertion tip can no longer be effectively attached to the cleaning device. Moreover, the mechanical integrity of the attachment of the tip, as well as the ability of the tip to resist camming or twisting forces, is markedly compromised after the tear strip has been engaged.
Preferably, the tear strip includes at least one weakened area used in combination with a pull tab which facilitates tearing of the strip relative to the insertion tip. In addition, the tip includes at least one alignment member to insure a proper angular orientation, relative to the and piece, when the tip is initially attached thereto.
As noted, the insertion tip includes a pair of adjacent interior chambers whereby liquid from a continuous fluid source, such as a faucet, is discharged through a first or inlet chamber in order to irrigate the body cavity (e.g., ear). An adjacent second or outlet chamber returns waste water discharged away from the body cavity for disposal. The inlet chamber includes a tip orifice sized to discharge liquid at a predetermined rate in relation to a distal tip orifice of the insertion tip. Preferably, the tip orifice of the inlet chamber is off center relative to the distal tip opening of the insertion tip to maximize the passageway for flushed particulate, such as cerumen.
The second or outlet chamber further includes at least one filter for capturing particulates (e.g., cerumen) contained in the waste water. Preferably, the insertion tip is made from a flexible transparent or translucent plastic material to permit a doctor or other user to verify that an effective cleaning procedure has been performed successfully. Furthermore, the filter is designed to be used one time, given that the filter will retain only a predetermined amount of particulate.
According to another preferred aspect of the invention there is provided, in combination, a disposable insertion tip for use with a body cavity cleaning device, said device including a handgrippable syringe which receives a supply of liquid under pressure for cleaning the body cavity and a return line for receiving used liquid and particulates from the body cavity. The insertion tip is releasably attachable to the syringe and includes release means for selectively releasing said insertion tip from said syringe, wherein engagement of said release means prevents effective reuse of said insertion tip in conjunction with said handgrippable syringe.
Preferably, the body cavity cleaning device is an ear irrigation apparatus in which the insertion tip is locked onto the syringe during assembly, the release means including at least one tear strip provided on the insertion tip.
According to yet another preferred aspect of the present invention, there is provided a disposable insertion tip which is releasably attachable to a body cavity cleaning device. The insertion tip includes release means for preventing the insertion tip from being removed from the cleaning device without disabling the insertion tip, thereby preventing reuse thereof
The insertion tip preferably includes a pair of interior chambers fluidly interconnected to the cleaning device which discharges liquid to a body cavity and removes waste liquid from the body cavity, respectively.
The release means unlocks the tip relative to a handpiece of the cleaning device onto which the tip is initially mounted and preferably includes at least one tear strip. Once the tear strip has been torn, the tip cannot effectively be reattached to the cleaning device rendering the tip useless. Furthermore, the tip cannot be removed from the handpiece without first employing the tear strip.
According to still another preferred aspect of the present invention, there is provided a method for preventing the reuse of a used insertion tip relative to a body cavity irrigation device, said method comprising the steps of attaching a insertion tip to said insertion device; pulling a frangible tear strip of said insertion tip; and removing the insertion tip from the device. The tear strip effectively disables the sealing capability of the insertion tip relative to the irrigation device once the tear strip has been torn and thereby prevents the tip from being successfully reused.
The attaching step includes the step of locking the insertion tip into engagement with the syringe wherein the insertion tip cannot be removed without first tearing the tear strip.
According to yet another preferred aspect of the present invention, there is provided a disposable insertion tip for use with a body cavity cleaning device, said insertion tip being adapted for releasable attachment to said device and including release means for selectively releasing the insertion tip from the cleaning device. The release means, upon engagement thereof, prevents effective reuse of said insertion tip in conjunction with the device. The tip is capable of circulating liquid to and liquid and particulates from a body cavity, said tip further including means for filtering the particulates. Preferably, the filtering means is provided in a return or outlet chamber of the insertion tip.
An advantage of the present invention is that a disposable insertion tip is provided which cannot be removed from a body cavity cleaning device, such as for ear irrigation, without disabling same.
A further advantage of the present invention is that the tear strip must be employed in order to release the insertion tip from the cleaning device. According to a preferred embodiment, the insertion tip, when initially attached to the syringe, effectively locks the tip in place. Therefore, any forced removal of the tip will require significant force and cause tearing of the tear strip, even when the strip is not first deliberately torn by the user. Therefore single use of an insertion tip, as described by the present invention, upon removal from a body cavity cleaning device, is virtually guaranteed.
Yet another advantage of the present invention is that a disposable tip such as described herein provides an effective fluid seal until the tear strip is acted upon. Use of the tear strip thereafter seriously destroys the sealing capability of the insertion tip should a user attempt to reattach a used tip to the irrigation device.
Yet another advantage of the present invention is that the tip is preferably made from a soft moldable plastic which provides comfort for a patient when the tip is inserted into a body cavity such as the ear. The tip, further being made from a translucent or transparent material also permits a user to visually note the efficacy of a cleaning procedure and to note when the filter is clogged, requiring the need for removal of the tip from the syringe. The described tip is also cost effective to manufacture, easy to use, and is efficient in design.
These and other objects, features, and advantages will become apparent from the following Detailed Description which should be read in conjunction with the accompanying drawings.